Long-term safety and efficacy of formoterol fumarate inhalation solution in patients with moderate-to-severe COPD.

ABSTRACT:

Background

Formoterol fumarate inhalation solution (FFIS; Perforomist^®) is a long-acting β₂-agonist (LABA) marketed in the US as a nebulized COPD maintenance treatment. Because long-term LABA use was associated with a potential increased risk of exacerbation or death in asthma patients, the US Food and Drug Administration (FDA) requested a postmarketing commitment study to evaluate long-term safety in COPD patients.

Methods

This was a multicenter, randomized, double-blind, placebo-controlled, noninferiority study. Patients (N=1,071; mean age, 62.6 years; 48.5% male; 89.7% white) with moderate-to-severe COPD on stable COPD therapy received FFIS (20 µg; n=541) or placebo (n=530) twice daily. The primary end point was the combined incidence of respiratory

SUBMITTER: Hanania NA 

PROVIDER: S-EPMC6311322 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature